MAUDE Adverse Event Report: EV3 NEUROVASCULAR HYPERGLIDE OCCLUSION BALLOON SYSTEM

Model Number 104-4113

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

It was reported the hyperglide balloon burst during preparation.No injury was reported as a result of the procedure.

Manufacturer Narrative

The balloon catheter was returned for evaluation with a guidewire of another manufacturer (not the x-pedion guidewire that was packaged with the balloon catheter) protruding from the distal lumen.The evaluation revealed the balloon could not maintain inflation due to damage to the chronoprene tubing; however, the cause of the damage could not be determined.All products are 100% inspected for damages and irregularities during manufacture.(b)(4).

• Brand Name: HYPERGLIDE OCCLUSION BALLOON SYSTEM
• Type of Device: OCCLUSION BALLOON SYSTEM
• Manufacturer (Section D): EV3 NEUROVASCULAR; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4097882
• MDR Text Key: 16173508
• Report Number: 2029214-2014-00531
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 104-4113
• Device Lot Number: 9899548
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1